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510(k) Data Aggregation
(61 days)
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#K913269) may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.
Indications Cleared via 510(k) #K971321 and 510(k) #K920037:
- Intercondylar fractures .
- Supracondylar fractures .
- . Unicondylar fractures
Expanded Indications (the subject of this premarket notification):
Fractures of the proximal femur:
- Transverse subtrochanteric fractures .
- . Short oblique subtrochanteric fractures
- . Long oblique subtrochanteric fractures
The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation of the fracture fragment
The Osteo Compression Condyle Screw System is a distal and proximal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K920037 and remain unchanged from these previous submissions.
The provided text is a 510(k) Premarket Notification Summary for the "Osteo Compression Condyle Screw System - Expanded Indications." This document details the submission of a medical device seeking clearance from the FDA, specifically for expanded indications of use for an existing device.
The fundamental aspect of a 510(k) submission, particularly for devices seeking clearance based on substantial equivalence to predicate devices, is to demonstrate that the new or modified device is as safe and effective as a legally marketed device (the predicate). This demonstration often relies on comparing design, materials, technological characteristics, and intended use, and not typically on extensive clinical trials demonstrating new performance metrics against specific acceptance criteria like those found in studies for novel technologies or drugs.
Therefore, for this specific submission, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) derived from a clinical study with a test set, ground truth established by experts, etc., are not applicable or present in the provided document.
Here's why and what information is available:
- Type of Device: The "Osteo Compression Condyle Screw System" is a bone fixation appliance used in orthopedic surgery to fix fractures. These are mechanical devices.
- Regulatory Pathway: This is a 510(k) submission for expanded indications. This pathway emphasizes substantial equivalence, not de novo clinical effectiveness.
- Focus of the Document: The document focuses on demonstrating that the expanded indications for the device (fractures of the proximal femur) are substantially equivalent to the predicate device (Synthes® Dynamic Condylar Screw System). The previously cleared indications (distal femur fractures) were already deemed substantially equivalent in prior 510(k)s (K971321 and K920037).
What the document does provide in lieu of "acceptance criteria" and performance studies:
The "acceptance criteria" for this type of submission are implicitly related to demonstrating substantial equivalence to the predicate device. This means showing that:
- Intended Use is the Same or Similar: The device is intended for similar types of femoral fractures.
- Technological Characteristics are the Same or Similar: The design and materials are the same or similar.
- Performance is the Same or Similar: While not explicitly detailed with quantitative metrics in this summary, the assumption is that the mechanical performance (stability, fixation strength) for the expanded indications is comparable to existing devices through design comparison.
Based on the provided text, I cannot complete the requested table or sections because the information typically associated with establishing acceptance criteria and performance against a test set (as would be done for AI/diagnostic devices) is not relevant to this 510(k) submission for a mechanical bone fixation device.
Here is a breakdown of why each requested point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" for this submission are a successful demonstration of substantial equivalence to a predicate device, as determined by the FDA. There are no reported numerical performance metrics like sensitivity or accuracy.
- Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study demonstrating performance metrics for a test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth established by experts for performance evaluation is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical device, not an AI or diagnostic device that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information relevant to the submission's approval:
- Predicate Device: Synthes® Dynamic Condylar Screw System
- Basis for Substantial Equivalence: Design and materials are substantially equivalent, and the expanded indications regarding proximal femoral fractures are comparable to the intended use of the predicate.
- Result: The FDA determined the device to be substantially equivalent for the expanded indications, allowing it to be marketed.
In conclusion, this document describes a 510(k) clearance for a mechanical medical device based on substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic or AI-driven device.
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